Back to resultsHigh Frequency Stimulation of the GPi or Thalamus in Tourette's Syndrome
Primary Purpose
Tourette's Syndrome
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
high frequency stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Tourette's Syndrome focused on measuring Tourette's syndrome, High frequency stimulation, Globus pallidus, Thalamus
Eligibility Criteria
Inclusion Criteria: Tourette's syndrome (DSM IV) inducing a disability in the social and personal life No improvement with medical treatment Severe self suffering Exclusion Criteria: Cognitive impairment (MMS < 24) Depression
Sites / Locations
- Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere
Outcomes
Primary Outcome Measures
Severity of tics
Secondary Outcome Measures
Full Information
NCT ID
NCT00139308
First Posted
August 30, 2005
Last Updated
August 30, 2005
Sponsor
Groupe Hospitalier Pitie-Salpetriere
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT00139308
Brief Title
High Frequency Stimulation of the GPi or Thalamus in Tourette's Syndrome
Official Title
Pilot Study of Internal Globus Pallidus or Median Centre of the Thalamus High Frequency Stimulation for the Treatment of Patients With Severe Tourette's Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Groupe Hospitalier Pitie-Salpetriere
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
5. Study Description
Brief Summary
Tourette's syndrome is a disabling neuropsychiatric disorder with major psychosocial consequences in some patients. The pathophysiology is still unknown. Some data suggest an dysfunction of limbic circuits in basal ganglia. The aim of this study is to evaluate the effect of high frequency stimulation of the internal part of the globus pallidus and/or parafascicular-median centre of the thalamus, two structures implicated in the limbic circuit, in patients with severe Tourette's syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette's Syndrome
Keywords
Tourette's syndrome, High frequency stimulation, Globus pallidus, Thalamus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
high frequency stimulation
Primary Outcome Measure Information:
Title
Severity of tics
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Tourette's syndrome (DSM IV)
inducing a disability in the social and personal life
No improvement with medical treatment
Severe self suffering
Exclusion Criteria:
Cognitive impairment (MMS < 24)
Depression
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves Agid, MD, PhD
Organizational Affiliation
CIC-Pitié-Salpêtrière
Official's Role
Study Director
Facility Information:
Facility Name
Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
18625864
Citation
Welter ML, Mallet L, Houeto JL, Karachi C, Czernecki V, Cornu P, Navarro S, Pidoux B, Dormont D, Bardinet E, Yelnik J, Damier P, Agid Y. Internal pallidal and thalamic stimulation in patients with Tourette syndrome. Arch Neurol. 2008 Jul;65(7):952-7. doi: 10.1001/archneur.65.7.952.
Results Reference
derived
Learn more about this trial
High Frequency Stimulation of the GPi or Thalamus in Tourette's Syndrome
We'll reach out to this number within 24 hrs